NCT02799043
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
NA
COMPLETED
NCT02799043
INTERVENTIONAL
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
Inclusion Criteria:
* Experiencing at least one (1) documented episode of spontaneous persistent or paroxysmal atrial fibrillation during the last 3 months by rhythm strip/ECG.
* One (1) previous AF ablation (PVI-only - any technology) after Jan-01-2013, but NOT within the last 3 months.
* Left atrial diameter < 6.0 cm via transthoracic echo or transesophageal echo; or <6.5 cm via CT or MRI with 6 months prior to the procedure.
* Sustained spontaneous or induced AF (>5 min uninterrupted).
Exclusion Criteria:
* Presence of structural heart disease with clinical significance
* NYHA Class IV
* Ejection fraction < 35%
* Previous AF ablation within the last 3 months
* ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker.
* History of myocardial infarction (MI) within the past three (3) months
* Atrial clot/thrombus noted within 72 hours of the procedure
Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation
- DIAGNOSTIC
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- Type: PROCEDURE
- Name: Standard PVI
- Description: Standard PVI procedure without FIRMap.
- Arm Group Labels: Standard PVI
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- Type: PROCEDURE
- Name: FIRM-Guided Procedure and PVI
- Description:
- Arm Group Labels: FIRM-guided Procedure and PVI
- Abbott Medical Devices